A Phase III Clinical Trial of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
HPV InfectioN, HPV-Related Carcinoma
About this trial
This is an interventional prevention trial for HPV InfectioN focused on measuring HPV Infection HPV vaccine
Eligibility Criteria
Inclusion Criteria:
- non-gynecological related
- *Chinese women with a history of sexual life who are 18-45 years old at the time of enrollment and can provide legal identification;
- *Axillary body temperature <37.3℃ on the day of enrollment;
- The subjects themselves have the ability to understand the clinical trial and voluntarily sign the informed consent;
- Subjects have the ability to read, understand, and fill out research application forms such as diary cards/contact cards, and promise to follow the research requirements participate in follow-up visits;
- No previous HPV vaccination history, no commercially available HPV vaccine during the study period (about 6 years after enrollment) plan of;
The subject has a negative urine pregnancy test on the day before vaccination.
- Gynecology related
- *Effective contraception was taken from day 1 of last menstrual cycle to day 0 of the study, and no childbearing within 7 months after enrollment plan.
- *Before the gynecological visit and within 48 hours before any subsequent visit that includes a gynecological sample collection: asexual life (including same-sex or opposite-sex anal, vaginal or genital contact), unwashed/washed vagina (Except for normal bathing outside the vagina), no vaginal drugs or preparations are used.
Exclusion Criteria:
First dose exclusion criteria:
(Visits may be rescheduled if the criteria described in the "*" option are met at screening)
- Non-gynecological related
- * Those with abnormal blood pressure (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) on physical examination before vaccination;
- *3 months prior to vaccination or planned to receive any immune globulin or blood products within 7 months of enrollment;
- *Received any vaccine within 14 days prior to vaccination, or received live vaccine within 28 days;
- *3 days before vaccination, suffering from acute febrile illness (body temperature ≥38.5℃) or using antipyretic, analgesic and antiallergic drugs (eg: acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.);
- History of severe allergies/conditions requiring medical intervention (e.g. Anaphylactic shock, anaphylactic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, local allergic necrosis(Arthus reaction) etc.);
- Immunocompromised or diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia Blood disease, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammation STD or other autoimmune disease;
- 1 month before vaccination or plan to receive immunosuppressive therapy within 7 months after enrollment, such as oral administration for more than 2 consecutive weeks Oral or injectable systemic corticosteroid therapy (≥2 mg/kg/day or ≥20 mg/day prednisone or equivalent to prednisone) amount); however, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are not limited;
- Previous splenectomy or impaired spleen function;
- Those with previous or current severe liver, kidney and cardiovascular diseases, complicated diabetes, and malignant tumors;
- Have a history of epilepsy, convulsions, mental illness or a family history of mental illness;
- Suffering from thrombocytopenia or any coagulation disorder that can become a contraindication to intramuscular injection;
- Participate in other clinical studies (drugs, vaccines and medical devices) within 3 months before vaccination or during the planned study period;
The investigator believes that the subject has any other factors that are not suitable for participating in the clinical trial (such as: poor compliance or planning Permanent relocation from the area before the study is completed, etc.).
- Gynecology related
- *Pregnant, breastfeeding, or within 6 weeks of pregnancy at the time of the first dose of the vaccine;
- *The subject is in the menstrual period;
- *Acute lower genital tract infection (such as acute vulvitis/vaginitis/cervicitis, etc.) found by the naked eye during gynecological examination;
- Previous history of abnormal cervical cancer screening or lesions (including HPV DNA positive, squamous intraepithelial lesion (SIL)or atypical squamous cells of undetermined significance (ASC-US), atypical squamous epithelial cells - excluding high-grade squamous cells Intraepithelial lesions (ASC-H), atypical glandular cells (AGC) or with cervical intraepithelial neoplasia (CIN),Adenocarcinoma in situ (AIS) or cervical cancer, etc.);
- Past or current anal and genital diseases (such as vulvar intraepithelial neoplasia, vaginal intraepithelial neoplasia, genital warts,vulvar cancer, vaginal cancer and anal cancer, etc.);
- Previous hysterectomy or pelvic radiation therapy or severe cervical/vaginal dysplasia.
Exclusion criteria for 2nd and 3rd dose vaccination:
If any of the following occurs, the investigator will terminate the subject's vaccination with the investigational vaccine.
- Meet the first dose exclusion criteria 5, 6, 7, 8, 9, 12;
- Any other reasons that, in the judgment of the investigator, warrant discontinuation of the investigational vaccination.
Sites / Locations
- Hechi Yizhou District Center for Disease Control and Prevention
- Hezhou Center for Disease Control and Prevention
- Lianyuan Center for Disease Control and PreventionRecruiting
- Qiyang Center for Disease Control and PreventionRecruiting
- Yongji Center for Disease Control and Prevention
- Yuanqu Center for Disease Control and Prevention
- Mianyang Youxian District Center for Disease Control and Prevention
- Neijiang Shizhong District Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
experiment group
placebo
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the experiment vaccine
According to the 0, 2, and 6 months immunization program, intramuscular injection of the upper arm deltoid muscle, 3 doses of the placebo